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Insight Global MES Engineer (NJ) in Bridgewater, New Jersey

Job Description

An employer is seeking an MES Engineer for a large pharmaceutical client. This individual will be Reporting to the lead engineer and will be mentored by this individual. They will be Responsible for maintaining p1 p2 tickets as they run through patches. They will also be managing communication with teams -- patching schedule and ensuring patching goes smoothly as well as supporting the PO in defining the strategy for the technical solutions! (what opportunities are in the business where there are challenges in the system and how to make them better). They have 30 sites - 15-20 system configs between those sites and its an extremely complex environment.

* Support the End-to-End delivery of major Manufacturing application and platform development and support Services for our PAS-X MES system

* Identify optimization opportunities and execute to result in reduced Total cost of ownership while maintain established Service Levels. Establish standard processes.

* Lead extended, global, enterprise teams of internal and external professionals.

* Ensure execution excellence in the delivery of team and project objectives.

* Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.

* Assist in the delivery of application development and support services for Global and Regional and site-based MES systems, ensuring quality and timely delivery of services to consumers.

* Assist in support and delivery for existing manufacturing systems to ensure sites operate to business needs and issues are resolved as they arise.

* Provide innovative ways of problem solving and implementing system improvements.

* Act as subject matter expert on technical architectures and service platforms.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

   

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Skills and Requirements

- Strong MES PAS-X -- legacy Pas deployments

- Control, conditioning, and application monitoring experience

- Understanding system architecture from an MES perspective (not just working within MES and knowing how to use the controls -- but understanding how the system integrates, how controls were built, how to admin the system and troubleshoot in the event of an issue)

- Threat monitoring

- Understanding of security concepts -- risk exposure to MES systems

- Understanding quality constraints and responses from an FDA perspective (how quality impacts and what documents need to be followed for a change -- Pas change of system update (what SDLC/manufacturing docs need to be updated)

- Compliance procedures exposure - nextgen pasax exp

- Regulated industry experience

- Pharma experience

- CI/CD null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.

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